Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder

Lundbeck

Status and phase

Completed

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: Duloxetine

Drug: Escitalopram

Study type

Interventional

Funder types

Industry

Identifiers

NCT01148472

10990 (Registry Identifier)

2004-005069-39 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study was to compare the efficacy of escitalopram with that of duloxetine in outpatients with Major Depressive Disorder (MDD) after 24 weeks of treatment. The study hypothesis was that there were clinically important differences between the two drugs in terms of efficacy and adverse event profiles.

Full description

Depression is a common mental disorder that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. The lifetime prevalence of Major Depressive Disorder (MDD) in community samples is 10-25% for women and 5-12% for men. Depression may become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. At its worst, depression may lead to suicide. Depression is recurrent in 75-80% of patients and becomes chronic in 15-20% of depressed patients.

The selective serotonin reuptake inhibitors (SSRIs) have become the leading class of antidepressants throughout the world. The efficacy and safety of SSRIs in the treatment of depression has been demonstrated in several clinical trials. With respect to safety, the studies show an advantage for the SSRIs over the older antidepressants. If the prescribing physicians are to make a well-founded judgement in their choice of drug factors like efficacy, safety, quality of life, and health economics must be taken into consideration. The primary aim of this study is to compare the efficacy of escitalopram with that of the serotonin norepinephrine reuptake inhibitors (SNRIs) duloxetine in the treatment of MDD.

Enrollment

294 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient suffers from a primary diagnosis of MDD according to DSM-IV-TR criteria (classification code 296.xx; current episode assessed using the MINI)
The patient has a MADRS total score >=26 and a CGI-S score >=4 at the Baseline Visit

Exclusion criteria

Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
Female patients of childbearing potential who are not using effective contraception
Use of any psychoactive medication 2 weeks prior to screening and during the study

Other protocol-defined inclusion and exclusion criteria may apply.